1. Please read the following statements carefully and select the one response that best describes your education as it pertains to the Basic Requirement for this position. You must select one response. If your answer is 'A' below, you must provide a copy of your college transcript.A. I have successfully completed a full four-year course of study in an accredited college or university leading to a bachelor's or higher degree with a major study in an academic field related to health sciences or allied sciences appropriate to the work of the position, such as biology, chemistry, biochemistry, pharmacology, epidemiology, or other related biological and/or medical sciences.
2. Do you have one full year of specialized experience, equivalent to the GS-11 or higher grade level in the Federal Service, advising on regulations and administrative procedures related to a drug approval process; reviewing drug approval applications; identifying and resolving resource needs or conflicts, availability and scheduling of a health project; providing up-to-date status of project progress; and, participating in managing and coordinating a drug review process?A. Yes
3. Do you have one year of specialized experience, equivalent to the GS-12 or higher grade level in the Federal service, that included managing the review process for multiple classes of drugs or new chemical entities; interpreting and applying the FDA regulations, legislation, and administrative procedures of new drug development and approval; performing the full range of project management duties related to the drug review process; planning and organizing the work of review teams; and providing authoritative advice and counsel on the drug review process?A. Yes
For each of the following task statements, select one response below (A-E) that best describes your experience level.A- I have no experience in performing this work behavior.
4. Lead a drug review process for one or more classes of drugs from initial application submission to time of approval, termination, or withdrawal.
5. Manage and coordinate the work of the review team members for a specific drug application review or guidance to determine how much progress is being made and if any problems are surfacing.
6. Review applications to ensure compliance with legal, regulatory, and policy requirements.
7. Identify and coordinate the resolution of conflicting resource needs, availability, and scheduling.
8. Establish schedules and milestones to achieve review goals, assuring the timely completion of project activities.
9. Serve as the primary point of contact for the up-to-date status of project progress and representing the team activities to management.
10. Identify project activities or situations that may adversely impact project plan.
11. Monitor and report the status of activities within an assigned project.
12. Work with members of a scientific, regulatory and management review team to develop project plans, including setting time frames, milestones, and an agreed upon endpoint.
13. Negotiate timely resolution of scientific and regulatory conflicts or problems to avoid delays in achieving project goals.
14. Liaise between cross functional teams, such as chemistry reviewers, compliance staff, and project management staff.
15. Participate in discussions regarding the implementation of new regulatory requirements, policies, and procedures for a drug review process.
16. Provide authoritative advice and counsel to all parties engaged or interested in the drug review process concerning the assigned drug reviews.
17. Advise supervisors, team members, and management of potential impact to project situations and recommend innovative solutions to problem areas.
18. Respond to inquiries and/or provide information on proposed legislation to state, local and federal officials.
19. Discuss the management of the drug review process to resolve technical and legal issues related to drug approval.
20. Write, edit, and/or review official correspondence regarding action, policy issues or requests for additional information.
21. Develop issue based meeting agendas and official meeting minutes.
22. Develop briefing papers and memos to provide upper level management with up-to-date status.
23. Draft reports on project schedule, costs, risks involved, and necessary tradeoffs to ensure program goals are being met.